Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
Recruiting · NCT05930483 · Interventional (participants receive a specific treatment) · Lead sponsor: Fred Hutchinson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second leading cause of cancer death among women in the US. There are population differences in breast cancer mortality, based on specific risk factors, including obesity. Cancer is the leading cause of death among Latinos, and among Latinas, breast cancer is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer breast cancer outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina breast cancer survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, to improve breast cancer survivorship.
Who can take part
Inclusion criteria
- Biologically female
- Age \>= 18 years
- Self-identifies Hispanic/Latina
- Able to read and write in Spanish and/or English
- Previous diagnosis of stage I-III BC within the past 5 years
- No evidence of current, recurrent, or metastatic disease
- 60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4/6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial)
- Body mass index (BMI) \>= 27 kg/m\^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Willingness to participate in all study activities
- Access to phone for study contacts
- Access to internet to participate in the online program and to be able to sync study devices
- Successful completion of at-home baseline assessments prior to randomization
Exclusion criteria
- Body mass index (BMI) \< 27 kg/m\^2 at time of baseline data collection
- Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)
- Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline
- Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine \[T-DM1\], trastuzumab deruxtecan \[T-DXd\])
- Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA
- Pregnant, breastfeeding, or planning to become pregnant during the study period
- Use of exogenous hormones for gender affirmation
- For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months
- For stool sample collection only: Presence of self-reported ileostomy or colostomy
- For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)
- Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation.
- Concurrent enrollment in another weight loss or physical activity trial
Where it is running
1 location listed across 1 US state.
- Fred Hutch/University of Washington Cancer Consortium - Seattle, Washington, United States